CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims priority to and the benefit of
U.S. Provisional Patent Application Number 62/515033, filed on June 5, 2017,
U.S. Provisional Patent Application Number 62/515082, filed on June 5, 2017,
U.S. Provisional Patent Application Number 62/516733, filed on June 8, 2017,
U.S. Provisional Patent Application Number 62/618817, filed on January 18, 2018, and
U.S. Provisional Patent Application Number 62/649181, filed on March 28, 2018.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates to drills, anchor drivers, and a drill guide for drilling
a pilot hole at a surgical repair site and inserting a suture anchor in the pilot
hole and, more particularly, to a multi-barrel drill guide and anchor deployment assembly
for both drilling a pilot hole at a surgical repair site and inserting a suture anchor
into the pilot hole while maintaining alignment of the drill guide with the pilot
hole.
2. Description of Related Art
[0003] Many orthopedic surgical and medical procedures require the fixation of one body
to another body. Such bodies may include bone, soft tissue, and prosthetics. One body
can be fixed in a position relative to another using connector devices, such as screws
and suture anchors (e.g., cannulated knotless suture anchors and soft all suture anchors).
For example, various orthopedic surgeries require the insertion and fixation of a
suture anchor within a bone. In such surgeries, prior to insertion of a suture anchor,
a pilot hole is drilled into the bone. Traditionally, a standard single barrel drill
guide is placed at the desired pilot hole location on the bone and a drill is placed
through the drill guide to create the pilot hole. The drill is then removed and replaced
with a driver pre-loaded with the suture anchor. Thus, a surgeon must completely remove
the drill from the drill guide and insert the driver all while maintaining alignment
of the drill guide with the pilot hole. Exchanging tools within the drill guide after
creation of the pilot hole increases the risk that the alignment of the drill guide
with the pilot hole will be lost. A loss of alignment requires additional surgical
time to correct the misalignment, if even possible, and may potentially result in
trauma to the tissue or bone surrounding the pilot hole. Loss of alignment can also
result in the anchor inserter rod bending or the anchor not being able to insert fully
into the pilot hole which can add cost as well as surgical time. To avoid misalignment
with a standard single barrel guide, an additional assistant may be required to help
maintain alignment or attempt realignment.
[0004] In addition, traditional suture anchors deployed by conventional drivers are often
too large for procedures that involve soft tissue fixation in the extremities. A bone
hole drilled in an extremity must be shallow and have a narrow diameter due to the
very nature of the location of the procedure. A shallow bone hole requires that the
anchor have exceptional retention capacity, because any movement of the anchor away
from the shallow bone hole might entirely release the anchor from the bone hole. At
the very least, the anchor may extend out of the shallow and narrow bone hole. III-fitting
suture anchors have increased instability and can cause irritation or damage to tissue
surrounding the exposed portion of the anchor.
[0005] Attempts at addressing the problem include scaling down the size of a traditional
suture anchor to fit within a shallow and narrow bone hole. However, as the size of
the traditional suture anchor decreases, the anchor loses retention capacity and thus
is unstable within the bone hole. Although numerous factors can influence the retention
capacity of a suture anchor, such as the type of tissue, the size of the bone hole,
and the anchor's design, the method of deployment of the suture anchor can also influence
a suture anchor's retention capacity.
[0006] Therefore, there is a need for an assembly requiring minimal movement and surgical
time for drilling a pilot hole, and inserting and deploying a suture anchor with reliable
retention capacity.
[0007] Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products
are discussed above in this Description of the Related Art Section or elsewhere in
this disclosure, these discussions should not be taken as an admission that the discussed
patents/publications/products are prior art for patent law purposes. For example,
some or all of the discussed patents/publications/products may not be sufficiently
early in time, may not reflect subject matter developed early enough in time and/or
may not be sufficiently enabling so as to amount to prior art for patent law purposes.
To the extent that specific patents/publications/products are discussed above in this
Description of the Related Art Section and/or throughout the application, the descriptions/disclosures
of which are all hereby incorporated by reference into this document in their respective
entirety(ies).
BRIEF SUMMARY OF THE INVENTION
[0008] Embodiments of the present invention recognize that there are potential problems
and/or disadvantages with the conventional single barrel drill guide (as discussed
herein and above). For example, removing a drill bit from the drill guide and replacing
it with a driver to insert the suture anchor increases the risk of misalignment of
the drill guide with the pilot hole, which requires additional surgical time and risks
trauma to the surrounding tissue and bone. Therefore, a need exists for a simple to
use multi-barrel drill guide and anchor deployment assembly that is configured to
simultaneously accommodate both a drill bit and a driver with a suture anchor. Such
a structural configuration allows for the suture anchor to be in position with the
anchor driver in a separate but converging pathway/channel in the drill guide and
ready for insertion into a pilot hole immediately after the pilot hole is formed by
the drill bit. This can be done without having to pull the drill bit out of the drill
guide prior to being able to insert the suture anchor driver into the post-convergent
area of the drill guide. Various embodiments of the present invention may be advantageous
in that they may solve or reduce one or more of the potential problems and/or disadvantages
discussed herein.
[0009] The present disclosure is directed to an inventive configuration, structure, and
resulting function of a multi-barrel drill guide and anchor deployment assembly. The
multi-barrel drill guide and anchor deployment assembly includes an elongated body
extending along a longitudinal axis having a proximal end and a distal end with a
handle extending from the elongated body at an angle from the longitudinal axis (at
an acute angle or orthogonal from the longitudinal axis) at a position between the
proximal end and the distal end. The assembly also includes an elongated distal guide
tube attached to and extending from the distal end of the elongated body. A sliding
inserter is movably connected to the elongated body such that the sliding inserter
is configured to move between the proximal end and the distal end of the elongated
body. The assembly also has a first channel, which extends from the proximal end to
the distal end, and a second channel which extends from the distal end to a position
between the distal end and the proximal end along the elongated body. The second channel
extends at an angle relative to the first channel. The first channel and the second
channel intersect at a convergence area at the distal end. In an embodiment, the convergence
area extends to a single exit point. In another embodiment, the single exit point
is at a distal end of the elongated distal guide tube.
[0010] The multi-barrel drill guide and anchor deployment assembly is configured to accommodate
a suture anchor and driver movable in a slidable manner within the first channel and
connected to the sliding inserter, and a drill bit movable in a slidable manner within
the second channel. In an embodiment, the second channel curves in a direction away
from the handle. In another embodiment, a portion (or bent portion) of the second
channel extends at an angle relative to the longitudinal axis that is different from
the remainder of the second channel. In accordance with an embodiment, the elongated
body has an optional slot/slit for a filament (or suture) connected to the anchor
positioned through the outside surface of the elongated body (and preferably into
the first channel). In another embodiment, the assembly includes a locking mechanism
configured to selectively lock the sliding inserter in place with respect to the elongated
body. In an embodiment, the locking mechanism includes an opening in the sliding inserter
selectively aligned with an opening in the elongated body, which extends to the second
channel. In a locked position, the drill bit extends through the opening of the sliding
inserter and the opening in the elongated body into the second channel.
[0011] In another embodiment of the assembly, the elongated body includes a recess and a
shallow deployment button hingedly connected within the recess. In an embodiment,
the driver is connected to the sliding inserter and sliding the driver distally along
the first channel rotates the shallow deployment button from the recess.
[0012] According to an another aspect, a method of drilling a pilot hole and inserting a
suture anchor in the pilot hole includes, but is not limited to, the steps of: (i)
providing a multi-barrel drill guide and anchor deployment assembly with an elongated
body extending along a longitudinal axis having a proximal end and a distal end, a
handle extending from the elongated body at an angle from the longitudinal axis (at
an acute angle or orthogonal from the longitudinal axis) at a position between the
proximal end and the distal end, and an elongated distal guide tube attached to and
extending distally from the distal end of the elongated body, a sliding inserter movably
connected to the elongated body such that the sliding inserter is configured to move
between the proximal end and the distal end of the elongated body, a first channel
extending from the proximal end to the distal end, a second channel extending from
the distal end to a position between the distal end and the proximal end along the
elongated body, the second channel at an angle relative to the first channel, and
a convergence area at the distal end where the first channel and the second channel
intersect; (ii) inserting a suture anchor loaded on an anchor driver into the first
channel; (iii) inserting a drill bit into an opening on the sliding inserter and an
opening on elongated body, which extends into the second channel; (iv) positioning
a distal end of the distal guide tube against a bone; (v) extending the drill bit
through the second channel, the convergence area and the distal guide tube; (vi) drilling
a pilot hole into the bone with the drill bit; (vii) retracting the drill bit past
the opening on the sliding inserter; (viii) extending the anchor driver through the
first channel and the convergence area; (ix) implanting the suture anchor into the
pilot hole. The above referenced method can be performed with the drill bit being
positioned within the first channel and the driver with the suture anchor being positioned
within the second channel.
[0013] Suture material or sutures, as the terms are used and described herein, can include
monofilament or multi-filament suture as well as any other metallic or non-metallic
filamentary or wire-like material suitable for performing the function of a suture.
This material can include both bioabsorbable and non-absorbable materials.
[0014] Suture anchors, as the term is used herein, can include soft suture anchors and rigid
suture anchors. Soft suture anchors are formed from filaments of suture material which
are retained within pre-formed bone holes by being deformable to increase their diameter
to a size greater than that of the bone hole, to thereby reside within the cancellous
bone and under the bone cortex. One such suture anchor is disclosed in
U.S. Patent No. 9826971 assigned to the assignee hereof and incorporated by reference herein in its entirety.
Since soft anchors are commonly made entirely of suture materials, they are sometimes
called "all-suture" anchors, and generally include a fibrous construct anchor body
portion (or fibrous, braided or woven fabric-type structure such as a flexible web,
as described in
U.S. Pat. No. 9173652) and a suture or filament portion. Methods and devices for inserting/deploying such
all-suture anchors are known, examples of which are disclosed in
U.S. Pat. No. 9173652.
[0015] As described in
U.S. Pat. No. 8409252, for example, "non-soft," "hard" or "rigid" suture anchors generally include a "hard"
anchor body portion (that may or may not include inner and outer members) and a suture/filament
portion. The anchor body of such suture anchors may be formed of a biocompatible and/or
bioabsorbable material. These materials may be of such composition that they are reabsorbed
by the body, e.g., during the healing process of the bone. Exemplary materials that
are suitable for use in the inner and outer members include, but are not limited to,
polyetheretherketone ("PEEK"), polylactic acid/beta-tricalcium phosphate ("PLA/Beta-TCP")
composites, ultra-high molecular weight polyethylene ("UHMWPE"), as well as other
metallic, non-metallic, and polymeric materials.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0016] The present invention will be more fully understood and appreciated by reading the
following Detailed Description in conjunction with the accompanying drawings. The
accompanying drawings illustrate only typical embodiments of the disclosed subject
matter and are therefore not to be considered limiting of its scope, for the disclosed
subject matter may admit to other equally effective embodiments. Reference is now
made briefly to the accompanying drawings, in which:
FIG. 1 is a first side view schematic representation of a multi-barrel drill guide
and anchor deployment assembly in the pre-drill, pre-anchor deployment, pre-actuated
configuration according to an embodiment;
FIG. 2 is a first side view schematic representation of a multi-barrel drill guide
and anchor deployment assembly in the drill, pre-anchor deployment, pre-actuated configuration
according to an embodiment;
FIG. 3 is a cross-sectional first side view schematic representation of the multi-barrel
drill guide and anchor deployment assembly of FIG. 2 according to an embodiment;
FIG. 4 is a close-up cross-sectional first side view schematic representation of a
locking mechanism of the multi-barrel drill guide and anchor deployment assembly of
FIG. 2 according to an embodiment;
FIG. 5 is a cross-sectional front/perspective view schematic representation of the
locking mechanism of the multi-barrel drill guide and anchor deployment assembly of
FIG. 2 according to an embodiment;
FIG. 6 is a close-up second side view schematic representation of a notch of the locking
mechanism of the multi-barrel drill guide and anchor deployment assembly of FIG. 2
according to an embodiment;
FIG. 7 is a first side view schematic representation of a multi-barrel drill guide
and anchor deployment assembly in the post-drill, pre-anchor deployment, pre actuated
configuration according to an embodiment;
FIG. 8 is a close-up cross-sectional first side view schematic representation of the
second channel of the multi-barrel drill guide and anchor deployment assembly of FIG.
7 according to an embodiment;
FIG. 9 is a close-up first side view schematic representation of the shallow deployment
button of multi-barrel drill guide and anchor deployment assembly in the pre-actuated/undeployed
configuration according to an embodiment;
FIG. 10 is a close-up cross-sectional second side view schematic representation of
the shallow deployment button of the multi-barrel drill guide and anchor deployment
assembly of FIG. 9 according to an embodiment;
FIG. 11 is a close-up first side view schematic representation of the shallow deployment
button of multi-barrel drill guide and anchor deployment assembly actuated/undeployed
configuration according to an embodiment;
FIG. 12 is a close-up rear/perspective view schematic representation of the shallow
deployment button of FIG. 11 according to an embodiment;
FIG. 13 is a rear view schematic representation of the shallow deployment button of
FIG. 11 according to an embodiment;
FIG. 14 is a first side view schematic representation of the anchor driver of the
multi-barrel drill guide and anchor deployment assembly in the actuated/undeployed
configuration according to an embodiment;
FIG. 15 is a close-up review view schematic representation of the proximal ends of
the sliding inserter and elongated body of FIG. 14 according to an embodiment;
FIG. 16 is a close-up first side view schematic representation of the proximal ends
of the sliding inserter and elongated body of FIG. 14 according to an embodiment;
FIG. 17 is a close-up first side view schematic representation of the suture anchor
in the undeployed state on the anchor driver of the multi-barrel drill guide and anchor
deployment assembly according to an embodiment;
FIG. 18 is a first side view schematic representation of the shallow deployment button
of multi-barrel drill guide and anchor deployment assembly in the actuated/deployed
configuration according to an embodiment;
FIG. 19 is a close-up side/rear perspective view schematic representation of the shallow
deployment button of FIG. 18 according to an embodiment;
FIG. 20 is a close-up first side view schematic representation of the suture anchor
in the deployed state on the anchor driver of the multi-barrel drill guide and anchor
deployment assembly according to an embodiment;
FIG. 21 is a close-up side view schematic representation of the suture anchor of FIG.
20 with the multi-barrel drill guide and anchor deployment assembly removed according
to an embodiment;
FIG. 22 is a side view schematic representation of an embodiment of the suture anchor
in the undeployed configuration according to an embodiment;
FIG. 23 is a side view schematic representation of the suture anchor of FIG. 22 loaded
onto the anchor drive according to an embodiment r;
FIG. 24 is a side view schematic representation of the suture anchor of FIG. 22 loaded
onto the anchor driver and placed in a pilot hole according to an embodiment;
FIG. 25 is a side view schematic representation of the suture anchor of FIG. 22 between
the undeployed and deployed configurations according to an embodiment;
FIG. 26 is another side view schematic representation of the suture anchor of FIG.
22 between the undeployed and deployed configurations according to an embodiment;
FIG. 27 is a final side view schematic representation of the suture anchor of FIG.
22 between the undeployed and deployed configurations according to an embodiment;
FIG. 28 is a side view schematic representation of the suture anchor of FIG. 22 in
the deployed configuration according to an embodiment;
FIG. 29 is a side view schematic representation of the suture anchor of FIG. 22 in
the fully deployed configuration according to an embodiment;
FIG. 29A is a side view schematic representation of a suture anchor loaded onto the
anchor driver according to an alternative embodiment;
FIG. 29B is a side view schematic representation of the suture anchor of FIG. 29A
loaded onto the anchor driver in the partially deployed configuration according to
an alternative embodiment;
FIG. 29C is a side view schematic representation of the suture anchor of FIG. 29A
loaded onto the anchor driver in the fully deployed configuration according to an
alternative embodiment
FIG. 30 is a first side view schematic representation of an alternative embodiment
of the multi-barrel drill guide and anchor deployment assembly in the pre-drill, pre-anchor
deployment, pre-actuated configuration according to an embodiment;
FIG. 31 is a first side view schematic representation of the multi-barrel drill guide
and anchor deployment assembly of FIG. 30 in the drill, pre-anchor deployment, pre-actuated
configuration according to an embodiment;
FIG. 32 is a first side view schematic representation of the multi-barrel drill guide
and anchor deployment assembly of FIG. 30 in the post-drill, pre-anchor deployment,
pre-actuated configuration according to an embodiment;
FIG. 33 is a first side view schematic representation of the multi-barrel drill guide
and anchor deployment assembly of FIG. 30 in the post-drill, actuated/deployed configuration
with the suture anchor in the deployed state according to an embodiment;
FIG. 34 is a first side view schematic representation of the suture anchor of FIG.
33 in the deployed state according to an embodiment;
FIG. 35 is a side view schematic representation of an additional embodiment of the
suture anchor in the undeployed state according to an embodiment;
FIG. 36 is a side view schematic representation of the suture anchor of FIG. 35 shortened
and expanded in the deployed state according to an embodiment;
FIG. 37 is a side view schematic representation of a disposable drill with a pre-installed
drill bit according to an alternative embodiment;
FIG. 38 is a schematic representation of an all suture soft tissue fixation device
according to an embodiment;
FIG. 39 is a side view schematic representation of an anchor driver according to an
alternative embodiment;
FIG. 40 is a side view schematic representation of a portion of the anchor driver
of FIG. 39;
FIG. 41 is a perspective view schematic representation of a spool portion of the anchor
driver of FIG. 39;
FIG. 42 is a perspective view schematic representation of a safety bar portion of
the anchor driver of FIG. 39;
FIG. 43 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 39;
FIG. 44 is a top view schematic representation of a portion of the anchor driver of
FIG. 39;
FIG. 45 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 39;
FIG. 46 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 39;
FIG. 47 is a side perspective view schematic representation of a fully assembled anchor
driver of FIG. 39;
FIG. 48 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 49 is a side view schematic representation of a portion of the anchor driver
of FIG. 47;
FIG. 50 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 51 is a side view schematic representation of a portion of the anchor driver
of FIG. 47;
FIG. 52 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 53 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 54 is a top perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 55 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 47;
FIG. 56 is a perspective view schematic representation of an anchor in a fully deployed
configuration/position/state;
FIG. 57 is a side view schematic representation of an anchor driver according to an
alternative embodiment;
FIG. 58 is a side view schematic representation of a fully assembled anchor driver
of FIG. 57;
FIG. 59 is a side perspective view schematic representation of the anchor driver of
FIG. 57;
FIG. 60 is a side perspective view schematic representation of the anchor driver of
FIG. 57;
FIG. 61 is a side perspective view schematic representation of a portion of the anchor
driver of FIG. 57; and
FIG. 62 is a perspective view schematic representation of an anchor in a fully deployed
configuration/position/state.
DETAILED DESCRIPTION OF THE INVENTION
[0017] Referring now to the drawings, wherein like reference numerals refer to like parts
throughout, there is seen in FIG. 1 a fully assembled first side 103 view schematic
representation of a multi-barrel drill guide and anchor deployment assembly 100 in
the pre-drill, pre-anchor deployment, pre-actuated configuration according to an embodiment.
In the depicted embodiment, the assembly 100 includes, but is not limited to, a distal
elongated body 102 extending along a central longitudinal axis x-x having a proximal
end 104 and a distal end 106, a handle 108 (which can include gripping features 109)
extending from the elongated body 102 between the proximal end 104 and a distal end
106, a distal tube or guide tip 128 (which can include gripping projections or teeth
to assist with setting and maintaining position on bone) extending from the distal
end 106, and a proximal sliding inserter/anchor driver 118/114. The elongated body
102 has an exterior, portions of which are sufficiently enclosed (as described above
and shown in the FIGs.). The exterior portion of the elongated body 102 preferably
comprises no movable parts that complicate or interfere with easy use of the assembly
100.
[0018] As shown in FIG. 1, the handle 108 extends approximately perpendicular from the elongated
body 102 between the proximal end 104 and the distal end 106 to increase balance and
control of the assembly 100. However, the handle 108 may extend at various angles
relative to the central longitudinal axis x-x, from any location along the elongated
body 102, to provide stability when the user grips the handle 108 to place the assembly
100 against a desired pilot hole location on a bone.
[0019] Still referring to FIG. 1, the elongated body 102 comprises a slot 120 extending
in a proximal direction along an axis parallel to the central longitudinal axis x-x
from the distal end 106 through at least a distal portion of the elongated body 102,
through a first opening 107 (formed in the top of the handle 108 and/or in the elongated
body 102) and to a second larger opening 111 (formed in the top of the handle 108
and/or in the elongated body 102) which extends to the proximal end 104. The slot
120 and openings 107, 111 can extend along an axis perpendicular to the central longitudinal
axis x-x and through the elongated body 102 into a first channel 110 (see FIG. 5)
to the inside of a second side 105 of the assembly 100.
[0020] As shown in FIG. 1, a track 113 - including a first portion 113A positioned along
the inside of a second side 105, and second portion 113B positioned along the bottom
inside of the elongated body 102 - extends in a distal direction along an axis parallel
to the central longitudinal axis x-x from the proximal end 104 toward the distal end
106, ending at or before the distal end 106. The track 113 facilitates the movement
of the proximal sliding inserter 118 along an axis parallel to the central longitudinal
axis x-x from the proximal end 104 through at least a distal portion of the elongated
body 102 (as described in detail below).
[0021] The sliding inserter 118 comprises an anchor driver 114 attached thereto (shown in
FIGs. 5 and 10). In a pre-actuated/undeployed configuration, the anchor driver 114
of the sliding inserter 118 extends from the proximal end 104 of the elongated body
102 through at least a distal portion of the elongated body 102. However, in its pre-actuated/undeployed
configuration, the anchor driver 114 does not extend into the distal tube or guide
tip 128 (shown in FIG. 8). When fully assembled, the multi-barrel drill guide and
anchor deployment assembly 100 comprises a suture anchor 10 with a passing filament
11 loaded on the anchor driver 114 (described in detail later). As fully assembled,
the suture anchor 10 is loaded on distal end 115 of the anchor driver 114, while the
passing filament 11 extends along the length of the anchor driver 114 and is wrapped
around or otherwise secured by a loading mechanism 117 at a proximal end 119 of the
sliding inserter 118 (also shown in FIGs. 5 and 12). The proximal end can also include
a malleting section or area on the back surface of the proximal end. This malleting
section can provide a user with a surface to mallet and assist with setting and maintaining
the distal end of the guide tube 128 in bone prior to drilling the hole. In the depicted
embodiment, the loading mechanism 117 includes one or more notches 121 and a flexible
substrate 122. In one embodiment, the flexible substrate 122 is composed of a foam
material; however, any other semi-flexible material may be used. The flexibility of
the flexible substrate 122 is such that the flexible substrate 122 may be easily removed
from the sliding inserter 118 to free the passing filament 11 (which may or may not
be attached to needles, as should be understood by a person of skill in the art in
conjunction with a review of this disclosure). As shown, the flexible substrate 122
is sized or otherwise dimensioned to fit within a portion of the proximal end 119
of the sliding inserter 118. In the depicted embodiment, the passing filament 11 is
removably secured by the one or more notches 121 and the flexible substrate 122 to
allow for release of the suture anchor 10 from the assembly 100 when the suture anchor
10 is in a deployed state in a pilot hole.
[0022] Still referring to FIG. 1, the sliding inserter 118 also comprises an opening 123
configured to receive a drill bit 116. In the depicted embodiment, the opening 123
is located or otherwise positioned at a distal end 124 of the sliding inserter 118.
In the pre-drill configuration (FIG. 1) and drill configuration (FIGs. 2-3), the opening
123 on the sliding inserter 118 is aligned with an opening 125 on the elongated body
102. The opening 125 is located or otherwise positioned between the proximal end 104
and the distal 106 of the elongated body 102 and connects to a second channel 112
within the elongated body 102. Thus, in the pre-drill configuration shown in FIG.
1, the drill bit 116 extends through the opening 123 in the sliding inserter 118 and
into the opening 125 of the elongated body 102. In the drill configuration (shown
in FIGs. 2-3 and described in detail below), the drill bit 116 is advanced into the
second channel 112 of the elongated body 102 and through the connected distal tube
or guide tip 128. In comparison, in FIG. 1, the assembly 100 is in a pre-drill configuration
wherein the drill bit 116 extends only partially through the second channel 112 and
not through the distal tube or guide tip 128.
[0023] Turning now to FIG. 2, there is shown a fully assembled first side 103 view schematic
representation of a multi-barrel drill guide and anchor deployment assembly 100 in
the drill, pre-anchor deployment, pre-actuated configuration according to an embodiment.
In the depicted embodiment, the drill bit 116 is in the drill configuration such that
the drill bit 116 extends through the second channel 112 at a length corresponding
to the desired or proper depth for the pilot hole. In the embodiment shown, the drill
bit 116 comprises a depth stop 126 at its proximal end 127, which abuts the opening
123 in the sliding inserter 118 when the drill bit 116 has reached the proper depth
in the pilot hole. The depth stop 126 prevents the drill bit 116 from extending any
deeper into the bone than the proper depth for the pilot hole in a particular procedure.
Similarly, the depth stop 126 also allows the user to determine if the drill bit 116
has been advanced far enough into the bone. As shown in FIG. 2, in the drill configuration,
the distal end 129 of the drill bit 116 extends out from the distal tube or guide
tip 128 in order to drill the pilot hole.
[0024] Referring now to FIG. 3, there is shown a cross-sectional first side 103 view schematic
representation of the multi-barrel drill guide and anchor deployment assembly 100
of FIG. 2. In the depicted embodiment, the elongated body 102 comprises the first
channel 110 and the second channel 112 for receiving tools to drill the pilot hole
and to insert the suture anchor 10. As shown in FIG. 3, the first channel 110 extends
from proximal end 104 to the distal end 106 of the elongated body 102, while the second
channel 112 extends from the opening 125 on the elongated body 102 to the distal end
106. Thus, in the depicted embodiment, the first channel 110 and the second channel
112 have different entry points along the elongated body 102. The two separate entry
points accommodate the two tools - the drill bit 116 for drilling the pilot hole and
the anchor driver 114 for inserting the suture anchor 10 into the drilled pilot hole.
[0025] As recited above, the first channel 110 extends approximately straight in a distal
direction along an axis parallel to the central longitudinal axis x-x of the elongated
body 102 from the proximal end 104 to distal end 106. The second channel 112 extends
at an angle relative to the first channel 110 and to the central longitudinal axis
x-x, which allows the first channel 110 and the second channel 112 to have separate
entry points and one convergence area 130. Thus, although the first channel 110 and
the second channel 112 extend from different entry points along the elongated body
102, the first channel 110 and the second channel 112 share a convergence area 130
proximal to a single exit point on the distal end 106 of the elongated body 102. In
other words, the convergence area 130 is where the channels 110, 112 converge prior
(i.e., proximal) to the single exit point. In the depicted embodiment, the single
exit point is at a distal end 131 of the distal tube or guide tip 128.
[0026] Accordingly, the first channel 110 is separate and distinct from the second channel
112 between the entry points and the convergence area 130. Thus, a user can employ
the drill bit 116 in the second channel 112 by extending the drill bit 116 into the
convergence area 130 and out of the distal tube or guide tip 128, while the anchor
driver 114 can sit (be positioned and not move) in the first channel 110. As shown
in FIG. 3, the drill bit 116 is in the drill configuration with the distal end 129
of the drill bit 116 extending from the distal tube or guide tip 128 and the depth
stop 126 abutting the opening 123 on the sliding inserter 118.
[0027] Still referring to FIG. 3 and as stated above, the second channel 112 extends at
an angle relative to the central longitudinal axis x-x of the elongated body 102 and
away from the first channel 110 in the proximal direction. In the depicted embodiment,
the second channel 112 comprises a bend 132, which is curved in a direction away from
the first channel 110. The second channel 112 may comprise the bend 132 at any point
along the length of the second channel 112 between the convergence area 130 and the
opening 125 on the elongated body 102. This bend 132 is structured and configured
to position/guide the semi-flexible drill bit 116 through the angled second channel
112 and straight out of the distal tube or guide tip 128. Stated differently, the
bend 132 curves the semi-flexible drill bit 116 such that the drill bit 116 is at
an angle capable of exiting the distal tube or guide tip 128, which is aligned with
the first channel 110 (parallel to the central longitudinal axis x-x). As shown in
FIG. 3, the proximal end 127 of the drill bit 116 is at an angle relative to the distal
end 129 of the drill bit 116.
[0028] As shown in FIG. 3, the first channel 110 is substantially straight along the bottom
of the elongated body 102. When the drill bit 116 is in the drill configuration, the
drill bit 116 extends through the convergence area 130 and out of the distal tube
or guide tip 128. In the pre-drill configuration (shown in FIG. 1) and drill configuration,
the anchor driver 114 and suture anchor 10 is proximal the convergence area 130 in
the first channel 110. Without obstruction by the anchor driver 114 (and suture anchor
10) in the convergence area 130, the drill bit 116 is free to pass via the second
channel 112 through the convergence area 130 and out of the distal tube and guide
tip 128. However, the first channel 110 is aligned with the convergence area 130 and
the distal tube and guide tip 128 such that the anchor driver 114 can be easily extended
through the convergence area 130 and the distal tube and guide tip 128 without moving
the assembly 100 (after the drill bit 116 has been removed). The suture anchor 10
is less likely to miss the previously drilled hole, and is more likely to be inserted
in the pilot hole without adjusting the distal end 131 of the distal tube and guide
tip 128 to sufficiently line up the pilot hole for deployment of the suture anchor
10. Accordingly, if the position of the assembly 100 is maintained with respect to
the bone after the pilot hole has been drilled, the suture anchor 10 with passing
filament 11 should be able to be easily delivered into the previously formed pilot
hole without having to move or change the angle of the distal tube and guide tip 128
to locate the pilot hole.
[0029] Turning now to FIG. 4, there is shown is a close-up cross-sectional first side 103
view schematic representation of a locking mechanism 133 of the multi-barrel drill
guide and anchor deployment assembly 100 of FIG. 2. In the depicted embodiment, the
locking mechanism 133 comprises the drill bit 116, the opening 123 on the sliding
inserter 118 and the opening 125 on the elongated body 102. When the drill bit 116
extends through both openings 123, 125 such that the distal end 129 of the drill bit
116 passes through at least a portion of the second channel 112 (and the elongated
body 102) and the proximal end 127 of the drill bit 116 remains outside or exterior
to the elongated body 102, the drill bit 116 functions as a locking mechanism 133.
The drill bit 116 maintains the openings 123, 125 in alignment and thereby blocks
the sliding inserter 118 from advancing in the distal direction along the track 113.
Thus, the user can operate the drill bit 116 to drill the pilot hole without risking
unintentional movement of the anchor driver 114 (and the suture anchor 10).
[0030] Referring now to FIGs. 5-6, there are shown first side 103 and second side 105 views
of an illustrative embodiment of the locking mechanism 133. First, FIG. 5 shows a
cross-sectional front/perspective view of the locking mechanism 133 on the first side
103 of the assembly 100. In the depicted embodiment, movement of the sliding inserter
118 along the track 113 between the first side 103 and the interior of the second
side 105 of the assembly 100 is blocked or otherwise prohibited when the drill bit
116 extends through the opening 123 in the sliding inserter 118 and the opening 125
in the elongated body 102. Movement of the sliding inserter 118 is thus contained
to movement parallel to the central longitudinal axis x-x by the track 113 and is
either permitted or obstructed by the absence or presence, respectively, of the drill
bit 116.
[0031] Next, FIG. 6 shows a close-up second side 105 view of a notch 134 of the locking
mechanism 133 on the assembly 100 according to an additional embodiment of the locking
mechanism 133. In the depicted embodiment, the locking mechanism 133 additionally
comprises a notch 134 on the second side 105 of the assembly 100. As shown, the notch
134 extends outward from the elongated body 102. The notch 134 is configured to engage
with an aperture 135 in the sliding inserter 118. In the depicted embodiment, the
notch 134 and the corresponding aperture 135 are rectangular; however, any other compatible
configurations of the notch 134 and aperture 135 may be used.
[0032] Still referring to FIG. 6, in the pre-drill configuration (FIG. 1) and the drill
configuration (FIGs. 2-3), the aperture 135 is engaged with the notch 134. In particular,
the aperture 135 surrounds the notch 134. When the drill bit 116 is removed from the
assembly 100, the user advances the sliding inserter 118 or otherwise applies force
to the proximal end 119 of the sliding inserter 118 in the distal direction. Such
force causes the aperture 135 of the sliding inserter 118 to slide past the notch
134 on the elongated body 102. The sliding inserter 118 may then continue to advance
in the track 113 to place the suture anchor 10 in the pilot hole. To reset the assembly
100 (i.e., reload the assembly 100 with a new suture anchor), the user moves the sliding
inserter 118 along the track 113 in the proximal direction until the aperture 135
of the sliding inserter 118 engages or otherwise locks over the notch 134 on the elongated
body 102. When the notch 134 is aligned with the aperture 135, the opening 123 in
the sliding inserter 118 is aligned with the opening 125 in the elongated body 102.
When the assembly 100 is reset and the aperture 135 is locked over the notch 134,
the sliding inserter 118 cannot move any farther in the proximal direction.
[0033] Turning now to FIG. 7, there is shown a first side 103 view schematic representation
of a multi-barrel drill guide and anchor deployment assembly 100 in the post-drill,
pre-anchor deployment, pre-actuated configuration according to an embodiment. In the
pre-drill and drill configurations shown in FIGs. 1-3, a suture anchor 10 has been
pre-loaded onto the distal end 115 of the anchor driver 114 of the sliding inserter
118. In such configurations, the distal end 115 of the anchor driver 114 (with the
suture anchor 10) extends through the first channel 110 up to the convergence area
130, but not into the convergence area 130. After the pilot hole has been drilled
and the drill bit 116 has been removed, as shown in the post-drill configuration of
FIG. 7, the anchor driver 114 (with the suture anchor 10) is free to move through
the convergence area 130 and out of the distal tube and guide tip 128.
[0034] Referring briefly to FIG. 8, there is shown a close-up cross-sectional first side
103 view schematic representation of the second channel 112 of the multi-barrel drill
guide and anchor deployment assembly 100 of FIG. 7. In the depicted embodiment, the
drill bit 116 has been removed from the assembly 100 after the pilot hole has been
drilled. As also shown in FIG. 7, the anchor driver 114 is free to advance along the
first channel 110 via the sliding inserter 118. The sliding inserter 118 is free to
move in the distal direction along the track 113 because the drill bit 116 is no longer
in place to act as the locking mechanism 133 between the sliding inserter 118 and
the elongated body 102.
[0035] Turning now to FIG. 9, there is shown a close-up first side 103 view schematic representation
of a shallow deployment button 136 of multi-barrel drill guide and anchor deployment
assembly 100 in the pre-actuated/undeployed configuration according to an embodiment.
A shallow deployment button 136 is located between the proximal end 104 and the distal
end 106 of the elongated body 102. In the depicted embodiment, the shallow deployment
button 136 is located or otherwise positioned within a recess 137 on the first side
103 of the elongated body 102. However, the shallow deployment button 136 may be positioned
at other appropriate locations along the elongated body 102. As shown in FIG. 9, the
shallow deployment button 136 is substantially flush with the first side 103 of the
elongated body 102 to prevent potential interference with use of the assembly 100
before the suture anchor 10 is deployed.
[0036] Still referring to FIG. 9, the shallow deployment button 136 is hingedly connected
to the elongated body 102 within the recess 137. In the depicted embodiment, one side
of the shallow deployment button 136 is connected to the elongated body 102 via a
hinge 138 in the recess 137. In the pre-actuated/undeployed configuration (shown in
FIG. 9), the shallow deployment button 136 has a flange 139 which extends from the
recess 137 into the first opening 107 (formed in the top of the handle 108 and/or
in the elongated body 102). In particular, the flange 139 extends into the path of
the track 113.
[0037] Referring now to FIG. 10, there is shown a close-up cross-sectional second side 105
view schematic representation of the shallow deployment button 136 of the multi-barrel
drill guide and anchor deployment assembly of FIG. 9. In a post-drill configuration,
as described above, the sliding inserter 118 is free to advance along the track 113.
The sliding inserter 118 moves along the track 113 until a portion 140 of the sliding
inserter 118 contacts the flange 139 of the shallow deployment button 136, which extends
into the path of the track 113, as shown in FIG. 9.
[0038] Turning now to FIG. 11, there is shown a close-up first side 103 view schematic representation
of the shallow deployment button 136 of multi-barrel drill guide and anchor deployment
assembly 100 in the actuated/undeployed configuration according to an embodiment.
After the portion 140 of the sliding inserter 118 contacts the flange 139 of the shallow
deployment button 136 in FIG. 10, continuing to advance the sliding inserter 118 in
the distal direction causes the portion 140 of the sliding inserter 118 to apply force
on the flange 139. Force on the flange 139 rotates the shallow deployment button 136
about the hinge 138, thereby rotating the shallow deployment button 136 out from the
recess 137 to an actuated/undeployed configuration. The portion 140 of the sliding
inserter 118 applies force on the flange 139 until the flange 139 is rotated out of
the path of the track 113. With the flange 139 out of the path of the track 113, the
sliding inserter 118 can advance farther distally along the track 113 to insert the
suture anchor 10 into the pilot hole. When the flange 139 is out of the path of the
track 113, the passing filament 11 extends in the first channel 110 and first opening
107 between the flange 139 and a feature 142 in the first opening 107 of the elongated
body 102.
[0039] Referring now to FIGs. 12-13, there is shown a close-up rear/perspective view and
rear view schematic representations of the shallow deployment button 136 of FIG. 11.
FIGs. 12-13 show the shallow deployment button 136 in the actuated/undeployed configuration
after it is rotated from the recess 137. The shallow deployment button 136 comprises
an indicator 141 which provides instructions for the user. In the depicted embodiment,
the indicator 141 is an arrow pointing downward toward the feature 142 on the elongated
body 102. In order to deploy and release the suture anchor 10 from the assembly 100,
the user will press the shallow deployment button 136 downward toward the feature
142 (i.e., in the direction of the indicator 141) (as described in detail below).
[0040] Turning now to FIGs. 14-15, there is shown a first side 103 view and close-up rear
view schematic representations of the anchor driver 114 of the multi-barrel drill
guide and anchor deployment assembly 100 in the actuated/undeployed configuration
according to an embodiment. When the flange 139 is rotated out of the path of the
track 113, the sliding inserter 118 can advance along the track 113 in the distal
direction. As the sliding inserter 118 moves in the distal direction, the anchor driver
114 connected thereto also moves in the distal direction out of the distal tube and
guide tip 128, as shown in FIG. 14. The anchor driver 114 (and the sliding inserter
118) are advanced until the suture anchor 10 loaded on the distal end 115 of the anchor
driver 114 is fully inserted in the pilot hole. When the sliding inserter 118 is advanced
as far as possible, a proximal end surface 143 of the sliding inserter 118 is substantially
flush with a proximal end surface 144 of the elongated body 102, as shown in FIG.
15. The substantial alignment of the proximal end surface 143 of the sliding inserter
118 and the proximal end surface 144 of the elongated body 102 provides confirmation
to the user that the suture anchor 10 is fully inserted in the pilot hole.
[0041] Referring now to FIG. 16, there is shown a close-up first side 103 view schematic
representation of the proximal ends 104, 119 of the elongated body 102 and sliding
inserter 118 of FIG. 14. In the depicted embodiment, the suture anchor 10 on the distal
end 115 of the anchor driver 114 has been fully inserted into the pilot hole. As such,
the proximal end surface 143 of the sliding inserter 118 is substantially flush with
the proximal end surface 144 of the elongated body 102. As shown in FIG. 16, the portion
140 of the sliding inserter 118 comprises a shallow channel 145. In the actuated/undeployed
configuration shown, the shallow channel 145 is substantially aligned with the hinge
138 above the feature 142 on the elongated body 102. When the shallow channel 145
is substantially aligned with the hinge 138 above the feature 142, the user can press
or otherwise apply pressure/force downward on the shallow deployment button 136 toward
the feature 142 (in the direction of the indicator 141). The shallow deployment button
136 moves downward via the hinge 138 and through the shallow channel 145 toward the
feature 142 to deploy the suture anchor 10.
[0042] Turning now to FIG. 17, there is shown a close-up first side 103 view schematic representation
of the suture anchor 10 in the undeployed state on the anchor driver 114 of the multi-barrel
drill guide and anchor deployment assembly 100. In the depicted embodiment, the suture
anchor 10 is shown in the undeployed state loaded on the anchor driver 114 (extending
from the distal tube or guide tip 128). In the particular embodiment of the suture
anchor 10 in FIG. 17, the suture anchor 10 comprises a first arm 12 and a second arm
13 which extend proximally toward the distal tube or guide tip 128 in the undeployed
state.
[0043] Referring now to FIG. 18, there is shown a first side 103 view schematic representation
of the shallow deployment button 136 of multi-barrel drill guide and anchor deployment
assembly 100 in the actuated/deployed configuration according to an embodiment. After
the anchor driver 114 has been fully advanced and the suture anchor 10 has been fully
inserted into the pilot hole, the suture anchor 10 must be deployed and then released
from the assembly 100. To deploy the suture anchor 10, the user presses or otherwise
applies force downward on the shallow deployment button 136 (in its actuated/undeployed
configuration), as described above, resulting in the actuated/deployed configuration
as shown in FIG. 18.
[0044] Turning now to FIG. 19, there is shown a close-up side/rear perspective view schematic
representation of the shallow deployment button 136 of FIG. 18. When the shallow deployment
button 136 is pressed downward through the shallow channel 145 toward the feature
142 of the elongated body 102, the flange 139 presses or otherwise displaces the passing
filament 11 toward the feature 142, creating a new, longer path for the passing filament
11. In the depicted embodiment, the assembly 100 has an additional indicator window
146 formed in the handle 108 (and/or in the elongated body 102). The indicator window
146 comprises a shallow deployment clicker 147 and a ridge 148. The shallow deployment
button 136 is connected to the shallow deployment clicker 147 such that when the shallow
deployment button 136 is pressed downward to the actuated/deployed configuration,
the shallow deployment clicker 147 deflects over the ridge 148 in the indicator window
146, which is visible to the user. In an additional embodiment, movement of the shallow
deployment clicker 147 over the ridge 148 in the indicator window 146 causes an audible
noise (e.g., click), providing an additional indication to the user that the shallow
deployment button 136 is in the actuated/deployed configuration and the suture anchor
10 has reached the deployed state.
[0045] Referring now to FIG. 20, there is shown a close-up first side 103 view schematic
representation of the suture anchor 10 in the deployed state on the distal end 115
of the anchor driver 114 of the multi-barrel drill guide and anchor deployment assembly
100. From the undeployed state (shown in FIG. 17), actuation and deployment of the
shallow deployment button 136 displaces the path of passing filament 11, effectively
removing slack and pulling the passing filament 11 in the proximal direction. When
the passing filament 11 is pulled in the proximal direction, the first arm 12 and
the second arm 13 of the suture anchor 10 rotate in the distal direction toward each
other (as the anchor is prevented from being pulled proximally by a force imparted
in the opposite direction by the distal end of the anchor driver), as shown in FIG.
20 (and described below with reference to FIGs. 22-29). This causes the suture anchor
10 to fold itself further into the pilot hole and create a wedge which is wider than
the drill diameter and locks the suture anchor 10 into place.
[0046] Turning now to FIG. 21, there is shown a close-up first side 103 view schematic representation
of the suture anchor 10 of FIG. 20 with the multi-barrel drill guide and anchor deployment
assembly 100 removed. In the deployed state, as shown in FIGs. 20-21, the suture anchor
10 is removed from the assembly 100 by unwrapping or otherwise dislodging the passing
filament 11 from the one or more notches 121 and the flexible block 122 at the proximal
end 119 of the sliding inserter 118.
[0047] Referring now to FIGs. 22-29, there are shown various views schematic representations
of an embodiment wherein the suture anchor 10 is a shallow Y-Knot
®. One such suture anchor is disclosed in
U.S. Patent Application No. 15/687040 assigned to the assignee hereof and incorporated by reference herein in its entirety.
The suture anchor 10 of the shallow Y-Knot
® embodiment illustrated in FIGs. 22-29 is a fibrous construct (anchor body) 20 having
at least one passing filament 21 weaved therethrough. The fibrous construct 20 has
a first arm 22 and a second arm 23 (as the first and second arms 12, 13 shown in FIG.
17) with a proximal side 24 and a distal side 25 extending therebetween. The passing
filament 21 has a first end 26 and a second end 27 woven through the fibrous construct
20 in a T-shape in the undeployed (or pre-deployment) configuration. Importantly,
the fibrous construct 20 is thicker than the passing filament 21, providing greater
tensile strength to the fibrous construct 20 (as compared to the filament 21) to minimize
creep toward the top/proximal end of the pilot hole. If more tension is placed on
the passing filament 21, the fibrous construct 20 is configured to and will widen
and wedge into the bottom of the pilot hole to lock in place (based on the particular
placement of the passing filament 21 through the fibrous construct 20, the force and
location thereof imparted by the deployment device (e.g., anchor driver 114) on the
fibrous construct 20, and the characteristics of the fibrous construct 20 itself).
[0048] FIG. 23 shows one embodiment for passing locations 28 on the fibrous construct 20.
As shown, the passing filament 21 enters and exits the proximal side 24 and distal
side 25 of the fibrous construct 20 at a plurality of passing locations 28. The fibrous
construct 20 is then loaded onto an anchor deployment device/inserter, such as the
anchor driver 114 described above. Importantly, the fibrous construct 20 is positioned
within the anchor driver 114 such that the first end 26 of the filament 21 extends
along a first side 29 of the anchor driver 114 and second end 27 of the filament 21
extends along a second side 30 of the anchor driver 114.
[0049] Deployment of the fibrous construct 20 is further described and illustrated with
reference to FIGs. 24-29. As shown in FIG. 24, the fibrous construct 20 is implanted
by the anchor driver 114 into a preformed pilot hole 31. Once the fibrous construct
20 is loaded onto the anchor driver 114 (or other deployment device), the anchor driver
114 is used to push the fibrous construct 20 into a narrow preformed pilot hole 31
(e.g., 10 mm deep). Such a narrow pilot hole 31 is often formed in smaller bones by
necessity, such as those in extremities.
[0050] When the fibrous construct 20 enters the narrow pilot hole 31, the first arm 22 and
second arm 23 of the fibrous construct 20 begin to fold or otherwise bend in the proximal
direction the narrow width of the pilot hole 31, as shown in FIG. 24 (also shown in
FIG. 17). Then, to deploy the fibrous construct 20, the anchor driver 114 is held
in place, fully inserted in the pilot hole 31, while the first and second ends 26,
27 of the passing filament 21 are tensioned and pulled away from the fibrous construct
20 in the proximal direction. When the first and second ends 26, 27 of the passing
filament 21 are pulled, lengths of fibrous construct 20 between each of the passing
locations 28 are pulled closer together as slack in the passing filament 21 between
the passing locations 28 is minimized. Meanwhile, as a result, the first arm 22 and
the second arm 23 of the fibrous construct 20 begin to rotate in the distal direction,
as shown in FIG. 25.
[0051] To continue deployment of the fibrous construct 20, the first and second ends 26,
27 of the passing filament 21 are pulled farther and farther in the proximal direction
away from the fibrous construct 20 and additional slack of the passing filament 21
between the passing locations 28 in the fibrous construct 20 is reduced. As a result,
the first and second arms 22, 23 of the fibrous construct 20 continue to fold or otherwise
bend tighter in the distal direction, as shown in FIGs. 26-27, and pleats 32 begin
to form between adjacent passing locations 28. Due to the added tension, the first
and second arms 22, 23 of the fibrous construct 20 are pulled closer together toward
the central longitudinal axis x-x through the fibrous construct 20. As an additional
result, the pleats 32 become more defined, as shown in FIG. 28.
[0052] Thereafter, the first and second ends 26, 27 of the passing filament 21 are pulled
until there is no remaining slack between adjacent passing locations 28 in the fibrous
construct 20, as shown in FIG. 29 (and FIG. 21). Applying additional tension to the
first and second ends 26, 27 of the passing filament 21 strengthens the fibrous construct
20 by forcing the fibrous construct 20 to widen or expand inside the pilot hole 31
until it reaches a fully deployed configuration, as shown in FIG. 29. As the fibrous
construct 20 is compressed or gets shorter, the fibrous construct 20 expands in directions
perpendicular to its length (i.e., width or thickness) to set and secure the anchor
in place in the pilot hole 31.
[0053] The pleats 32 form a stack of the mattress thicknesses effectively increasing a diameter
(as measured in relation to the central longitudinal axis x-x of the fibrous construct
20 and the pilot hole 31). This relative increase in size in distance from the central
longitudinal axis x-x of the pilot hole 31 creates a retention force of the fibrous
construct 20, including the expansion in width and/or thickness described above. In
other words, Poisson's ratio of width and/or mattress thickness growth during a reduction
in length provides for an increase in deployment size that is additive to the increase
due to the pleats 32 force of the fibrous construct 20. Poisson's ratio defines the
proportional decrease in a longitudinal measurement to the proportional increase in
length in a sample of material that is elastically stretched. Therefore, if a material
is compressed in the x-direction, for example, the material will expand in the y-direction
and/or z-direction.
[0054] The passing filament 21 can be removed from the fibrous construct 20 by pulling either
end 26, 27 until the entire passing filament 21 is removed. The final form of the
fibrous construct 20 in the deployed state allows the passing filament 21 to easily
slide therethrough, as the fibrous construct 20 is set and secured in the pilot hole
31. That is, the tensile strength of the fibrous construct 20 in this configuration
is sufficient to keep the fibrous construct 20 in place while the passing filament
21 is easily removed.
[0055] Deployment of the fibrous construct 20 is further described and illustrated with
reference to FIGs. 29A-29C, in accordance with an alternative embodiment. FIG. 29A
shows the fibrous construct 20 in a similar undeployed position as the fibrous construct
20 in FIG. 24. FIG. 29B shows the fibrous construct 20 in a position about half way
to full deployment, and FIG. 29C shows the fibrous construct 20 in a fully deployed
configuration. The main difference between the embodiments shown in FIGs. 24-29 and
the embodiments shown in 29A-29C, includes the slack line that runs across the side
of the inserter 114 (no. "21" written on the line) in FIG. 29A, for example, where
the slack line runs across the distal end and partially inside the forked section
of the inserter 114 in FIG. 24. Other positioning configurations of the passing filament
21 through the fibrous construct 20, which allow the fibrous construct to perform
the same or similar functionality are contemplated and within the scope of this disclosure
(as should be appreciated by a person of ordinary skill in the art in conjunction
with a review of this disclosure).
[0056] Turning now to FIGs. 30-36, there are shown various views schematic representations
of an embodiment of the multi-barrel drill guide and anchor deployment assembly 100
wherein the suture anchor 10 is a Y-Knot
® anchor 40, for example, which can be any all suture anchor configured to perform
the same functionality as described herein (as should be understood by a person of
ordinary skill in the art in conjunction with a review of this disclosure). FIG. 30
shows the assembly 100 with a 1.3 mm or 1.8 mm Y-Knot
® all suture anchor. One such suture anchor is disclosed in
U.S. Patent No. 9826971 assigned to the assignee hereof and incorporated by reference herein in its entirety.
In the depicted embodiment and as described above, the drill bit 116 is loaded in
the second channel 112 into the convergence area 130 such that the drill bit 116 acts
as the locking mechanism 133 to ensure that the sliding inserter 118 will not move
in transportation or during handling until the drill bit 116 is used and removed.
In the depicted embodiment of the assembly 100 shown in FIG. 30, in addition to having
a different all suture anchor, the assembly 100 does not have the shallow deployment
button 136 or shallow deployment clicker 147 of the embodiment of the assembly 100
of FIGs. 1-22. Otherwise, the assembly 100 is the same as the assembly 100 described
and illustrated with respect to FIGS. 1-20.
[0057] FIG. 31 shows the drill bit 116 after it has drilled the proper depth for a pilot
hole in a bone. As with other embodiments of the assembly 100, the user will know
the proper depth has been reached because the depth stop 126 on the drill bit 116
will contact the opening 123 of the sliding inserter 118. FIG. 32 shows the assembly
100 after the drill bit 116 has been removed. The sliding inserter 118 is now free
to be advance along the track 113 and insert the Y-Knot
® 40 into a pilot hole. FIG. 33 shows the assembly 100 after the all suture anchor
40 is fully inserted into the pilot hole and deployed, while FIG. 34 shows the all
suture anchor 40 deployed after the assembly 100 is removed.
[0058] An embodiment of the Y-Knot
® anchor (or soft anchor or "all-suture" anchor) 40 is illustrated in detail in FIGs.
35-36. The all suture anchor 40, as shown in FIGs. 35-36, contains at least two sections:
at least one filament 41, which is a suture to be anchored; and a fibrous construct
(anchor body) 40, which is to form a portion of the anchor that can increase in width,
thickness and/or diameter and shrink in length as part of deployment. See FIG. 35,
showing the fibrous construct 40 in the undeployed state; and FIG. 36, showing the
fibrous construct 40 "shortened" and "expanded" in the deployed state, which is additive
to the increase due to the pleats). This soft anchor embodiment also takes advantage
of Poisson's ratio, which captures the following cause/effect relationship: compressing
a material in a first direction causes the material to expand in direction perpendicular
to the first direction (i.e., if compressed in the x-direction, the material will
expand in the y-direction and/or z-direction), and stretching/lengthening a material
in a first direction causes the material to contract in directions perpendicular to
the first direction. Although, it is the fibrous construct 40 that increases in width,
thickness and/or diameter at deployment, it should be understood that the filament
41 also plays a role in the deployment of the anchor even though the filament 41 may
remain free (in some embodiments) to slide, and non-slidable in others (at least at
a particular position or point in use) in relation to the fibrous construct 40. The
filament 41 helps to position, align and support the fibrous construct 40, such that
if the filament 41 were to be removed from the fibrous construct 40 after deployment
of the anchor, the fibrous construct 40 may be free to spill (i.e., release), allowing
the fibrous construct 40 to collapse and shrink in size, allowing for easy (and potentially
undesirable) removal.
[0059] In other words, the fibrous construct 40 has two primary functions. First, it becomes
a base for the filament 41 to slide within. Second, when compressed and/or pleated
during deployment, the fibrous construct 40 becomes more compact in one direction
thereby expanding outwardly and increasing its overall width, thickness or diameter
to create a retention capacity. This action of having the fibrous construct 40 change
in shape to increase its overall width, thickness or diameter is a useful characteristic
which may be used advantageously to secure the anchor in a hole or against a bony
or soft tissue. It is this combination of the expanding fibrous construct 40 coupled
with the filament 41 remaining slidable (in some embodiments; and non-slidable in
others, at least at a particular position or point in use) in relation to the fibrous
construct 40 that render embodiments of the present invention ideal for the reattachment
of soft tissue to bone or soft tissue to soft tissue where it is desirable to pass
sliding knots to secure a repair.
[0060] The discussion below relates to alternative embodiments of a disposable drill, and
of two different anchor drivers.
[0061] Turning to FIG. 37, a side view schematic representation of a disposable drill 300
with a pre-installed drill bit 302 according to an alternative embodiment is shown.
This disposable drill 300 and pre-installed drill bit 302 may be used in place of
drill bit 116, described above, or separately/independently therefrom. The disposable
drill can include, but is not limited to, a motor 301, a drill bit 302 attached to
the motor with a specified/predetermined length so that it is configured to create
an pilot hole with a desired length/depth for a particular procedure, disposable batteries
303 configured to supply power to the motor, and at least one switch 304 configured
to be actuated (rotationally, linearly, perpendicular to the longitudinal axis of
the device ("pushed")) by a user to turn on the drill bit 302, and/or set the desired
speed of the drill bit 302. The disposable drill 300 can also include a disposable
plastic housing 305 to make the device lightweight, less expensive, and disposable.
The disposable plastic housing 305 can be made from any plastic or combination of
plastics.
[0062] As discussed above, during suture anchor placement, a pilot hole is typically made
in bone before an anchor is inserted. The pilot hole is typically formed by using
a drill bit to drill a hole for placement of the anchor. However, conventionally,
a drill handpiece and battery must be sterilized and ready for use in the surgery.
Also, a drill bit is typically drilled a certain depth through a drill guide, so a
hard stop structure can be required on the drill guide, or a hard stop structure can
be placed on the drill handpiece at a certain location to create an appropriate hard
stop against the drill guide (as should be understood by a person of ordinary skill
in the art in conjunction with a review of this disclosure).
[0063] By providing disposable drill 300 in accordance with an embodiment, there is no need
for an additional drill handpiece and battery to be sterilized before the surgery.
Also with the drill bit 302 pre-installed on the disposable drill 200, the disposable
drill 300 is ready to use out of the package and does not require the additional step
of installing of the drill bit on the drill handpiece.
[0064] Generally, the following described and illustrated two alternative driver designs
are configured to work based on the same concept of pulling suture tails back/proximally
from an anchor to deploy the anchor (see, e.g., FIGs. 18-21 and related description).
The alternative driver designs may be used in place of the anchor driver 114, described
above, or separately/independently therefrom. Each of the following described and
illustrated anchor driver devices works with an all suture soft tissue fixation device
with a suture that is configured to slide after the anchor is deployed. In many procedures
that involve soft tissue fixation in the extremities, it is necessary to have an anchor
that can be deployed in a relatively shallow hole with a narrow diameter (as compared
with other locations in the body). The uniqueness of the all suture soft tissue fixation
device pertains, in part, to the weaving of the suture through the anchor which allows
the anchor to sufficiently deploy in the bone tunnel (preferably at the bottom of
the bone tunnel) while the driver is still inserted. The pattern which the suture
is weaved through the anchor is unique in that it preferably does not start and end
at the tips of the anchor (although, it can do so). Instead, it is started very close
to the center and woven to the tip at one end then from there to the opposite tip
and woven back to the center next to the starting position. Such a configuration is
illustrated in the FIG. 38. As shown, the all suture soft tissue fixation device includes
a fibrous construct (anchor body) 20 (e.g., no. 5 suture) having at least one passing
filament 21 (e.g., no. 0 suture) weaved therethrough, similar to the suture anchor
10 of the shallow Y-Knot
® embodiment illustrated in and described with respect to FIGs. 22-29. The weaving
of the suture/filament 21 through the fibrous construct 20 allows the anchor to deploy
while still on a driver by tensioning the first and second ends 26, 27 of the passing
filament 21 (similarly to FIGs. 18-21, 25-29, as described above, and below). The
design of the driver allows insertion of the anchor into the bone tunnel without use
of an additional guide, and deploys the anchor quickly by an actuation means (e.g.,
by squeezing or depressing of a lever). After deploying the anchor, the driver can
be removed and the suture can slide through the anchor. FIGs. 39-56 illustrate one
alternative embodiment of an anchor driver 200, and FIGs. 57-62 illustrate another
alternative embodiment of an anchor driver 400.
[0065] Turning to FIG. 39, there is shown a side perspective view of an alternative embodiment
of an anchor driver 200. The anchor driver 200 can include, but is not limited to,
a forked distal driver tip 201 to position a suture anchor 10 in a bone hole (not
shown). A depth stop 202 is positioned proximally of the forked distal driver tip
201, and is configured to ensure that the driver is inserted a predetermined depth
into the bone hole (e.g., 10 mm). A lever arm 203 is shown, which is configured to
displace suture attached to the anchor 10 in order to deploy the anchor 10 (described
below). A spool retaining arm 206 is also shown, and is configured to keep a suture
spool 205 (detailed below) in a locked position until the spool 205 is intentionally
released by a user. The anchor driver 200 can include a housing/cover (not shown)
to cover the internal parts. The anchor driver 200 is shown open without a housing/cover
to allow for illustration of the internal parts.
[0066] Turning to FIG. 40, a slot 207 is provided in the anchor driver 200 in which spool
205 sits. The slot 207 includes teeth 207A configured to engage and lock with teeth
205A of the spool (FIG. 41) when the spool 205 is fully inserted into a locked position
(described below). The spool retaining arm 206 is also configured to engage and lock
with teeth 205A of the spool (FIG. 41) when the spool 205 is fully inserted into a
locked position. A perspective view of the spool 205 is shown in FIG. 41, and includes
portions to wind suture 205B, 205C, and teeth 205A.
[0067] Referring to FIGs. 42 and 43, perspective views of the safety bar 204 alone and positioned
within the anchor driver 200, respectively, are shown. As shown in FIG. 43, the anchor
driver 200 is fully assembled (except for an optional housing/cover), and the spool
205 is shown in the locked position where the lateral surface 208 is positioned out
a predetermined distance from the side 209 of the anchor driver 200. In the locked
position, a portion of teeth 207A of the slot 207 is positioned in contacting relation
with a portion of teeth 205A of the spool 205, and the spool retaining arm 206 is
positioned between another portion of teeth 205A of the spool 205. In addition, the
safety bar 204 is shown positioned is a slot of the anchor driver 200 under the lever
arm 203 (which is configured to block the lever arm from contacting the suture limbs
26 and 27). The anchor 10 is also shown positioned on the forked distal driver tip
201.
[0068] FIG. 44 is a top perspective view of the distal end of the anchor driver 200 showing
the anchor 10 positioned on the forked distal driver tip 201 (in an undeployed configuration/position)
and ready for insertion into a bone hole.
[0069] FIG. 45 is a side perspective view of the spool 205 in the locked position (as described
above). As shown, the lateral surface 208 is positioned out a predetermined distance
from the side 209 of the anchor driver 200 to form a spool release button.
[0070] FIG. 46 is a side perspective view of the spool 205 in the unlocked/released position,
where the lateral surface 208 has been pushed/actuated by a user to be substantially
flush with the side 209 of the anchor driver 200. This position of the spool 205 releases
the teeth 205A of the spool 205 from the teeth 207A of the slot 207 and from the spool
retaining arm 206, allowing the spool 205 to freely spin and unwind the suture.
[0071] A method of using anchor driver 200 will now be described. In brief, the anchor driver
200 is preferably configured to be a single use device, and is packaged as shown in
FIG. 47 (showing a side perspective view of anchor driver 200 in an undeployed configuration).
After drilling a bone hole/tunnel (e.g., a 10mm deep and 1.5mm diameter hole), anchor
driver 200 is then inserted into the bone tunnel by striking the back of the driver
(as should be understood by a person of skill in the art in conjunction with a review
of this disclosure). When the built in depth stop 202 is flush with the top surface
of the bone, the safety bar 204 can be removed and the lever arm 203 is squeezed to
deploy the anchor 10 (see FIGs. 48-54). After the anchor 10 is deployed, the lateral
surface 208 of the spool 205 is pushed in to be flush with the side surface 209 of
the driver body, and the driver 200 is removed from the insertion site (FIG. 55).
By removing the driver 200 while holding the spool 205 in the released position, the
suture tails 26, 27 will unspool and free themselves from the driver (FIG. 56).
[0072] Turning to FIG. 48, the safety bar 204 is shown removed (after the anchor 10 is preferably
fully inserted into a bone hole) to allow deployment of the anchor 10.
[0073] Referring to FIG. 49, the lever arm 203 is actuated/pressed down by a user (similar
to the embodiment shown and described with respect to FIGs. 18-21), which deflects
the suture tails 26, 27 (only from the anchor/distal side and not the spool proximal
side because of the spool being in the locked position) to deploy the anchor 10.
[0074] Turning to FIG. 50, the tails of the anchor 10 are shown beginning to flip and point
in the opposite/distal direction, as the suture 21 slack is taken out of the anchor
by depressing the lever arm 203.
[0075] Turning to FIGs. 51 and 52, the lever arm 203 is shown being depressed about half
way over the suture limbs 26, 27, further deploying the anchor 10.
[0076] Turning to FIGs. 53 and 54, the lever arm 203 is shown fully depressed over the suture
limbs 26, 27, fully deploying the anchor 10 (preferably at the base of the bone hole).
[0077] Turning to FIG. 55, the lateral surface 208 of the spool 205 is shown pushed in to
be flush with the side surface 209 of the driver body, and the driver 200 is removed
from the insertion site which unspools the suture.
[0078] Referring to FIG. 56, the anchor 10 is shown in its fully deployed state (preferably
at the bottom of a bone hole) after the anchor driver 200 is removed.
[0079] Turning to FIG. 57, there is shown a side perspective view of an alternative embodiment
of an anchor driver 400. The anchor driver 400 can include, but is not limited to,
a forked distal driver tip 401 to position a suture anchor 10 in a bone hole (not
shown). A depth stop 402 is positioned proximally of the forked distal driver tip
401, and is configured to ensure that the driver is inserted a predetermined depth
into the bone hole (e.g., 10 mm). A lever arm 403 is shown, which is configured to
displace suture attached to the anchor 10 in order to deploy the anchor 10 by pushing
a sliding cleat 405 attached to the proximal end of the suture tails 26, 27 proximally
through a channel or groove 407 (further described below). A safety lever 404 is also
shown, and is configured to prevent the actuation of the lever arm 403 until when
appropriate. A cleat release notch 406 is also shown, which is configured to stop
the cleat 405 from freely falling out of the anchor driver 400 after the anchor 10
is deployed. As shown in FIG. 58, the anchor driver 400 can also include a housing/cover
408 to cover the internal parts (although, the anchor driver 400 is shown open without
a housing/cover in many of these figures to allow for illustration of the internal
parts).
[0080] As shown in additional figures identified below, the lever arm 403 is configured
to push the sliding cleat 405 back/proximally a predetermined distance (e.g., about
10mm, which is an example appropriate distance to deploy the anchor 10). After pushing
the cleat 405 proximally a predetermined distance, the lever arm 403 is configured
to be positioned fully outside the channel 407 of the sliding cleat 405. Because of
this, the sliding cleat 405 is configured to freely slide up to the cleat release
notch 406 at the distal end of the driver 400. At this point, the driver 400 can be
removed from the insertion site and the cleat 405 can be separated from the driver
400 with a pull on the suture tails 26, 27.
[0081] A method of using anchor driver 400 will now be described. In brief, the anchor driver
400 is preferably configured to be a single use device, and is packaged as shown in
FIG. 58 (showing a side perspective view of anchor driver 200 in an undeployed configuration).
After drilling a bone hole/tunnel (e.g., a 10mm deep and 1.5mm diameter hole), anchor
driver 400 is then inserted into the bone tunnel by striking the back of the driver
(as should be understood by a person of skill in the art in conjunction with a review
of this disclosure). When the built in depth stop 402 is flush with the top surface
of the bone, the lever arm 403 can be actuated by a user (e.g., squeezed) which pushes
the sliding cleat 405 proximally to tension the suture tails 26, 27 and deploy the
anchor (see FIG. 60). With the lever arm 403 fully depressed, the driver 400 can be
removed from the insertion site and the sliding cleat 405 is configured to pull out
from the front of the driver (see FIGs. 61, 62). Finally, the suture can be uncleated
from the sliding cleat 405 and the suture tails can be pulled to ensure that the anchor
is deployed.
[0082] Turning to FIG. 59, the anchor driver 400 is shown in an undeployed/unactuated position,
and is ready to deploy the anchor 10 into a bone hole (not shown).
[0083] Referring to FIG. 60, the anchor driver 400 is shown after the lever arm 403 has
been actuated making it clear of the channel 407, and the anchor 10 has been deployed.
[0084] Referring to FIG. 61, the sliding cleat 405 is shown positioned at the release notch
406, having moved through the channel 407 after the driver 400 has been removed from
the insertion site.
[0085] Turning to FIG. 62, the sliding cleat 205 is shown completely removed from the driver
400 and is ready to be uncleated to the anchor 10 through the suture tails 26, 27.
[0086] Filaments and sutures, as the terms are used and described herein, includes braided
(i.e., multi-filament) suture and monofilament suture as well as any other metallic
or non-metallic filamentary or wire-like material suitable for performing the function
of a suture. This material can include both absorbable and non-absorbable materials.
[0087] While embodiments of the present invention has been particularly shown and described
with reference to certain exemplary embodiments, it will be understood by one skilled
in the art that various changes in detail may be effected therein without departing
from the spirit and scope of the invention as defined by claims that can be supported
by the written description and drawings. Further, where exemplary embodiments are
described with reference to a certain number of elements it will be understood that
the exemplary embodiments can be practiced utilizing either less than or more than
the certain number of elements.
Aspect 1 of the invention relates to a multi-barrel drill guide, comprising:
an elongated body extending along a longitudinal axis having a proximal end and a
distal end with a handle extending from the elongated body between the proximal end
and the distal end;
an elongated distal guide tube attached to and extending distally from the distal
end of the elongated body;
a sliding inserter movably connected to the elongated body such that the slidable
inserter is configured to move between the proximal end and the distal end of the
elongated body;
a first channel extending from the proximal end to the distal end of the elongated
body;
a second channel extending from the distal end to a position between the distal end
and the proximal end along the elongated body, the second channel extending at an
angle relative to the first channel; and
a convergence area at the distal end where the first channel and the second channel
intersect.
Aspect 2 of the invention relates to a multi-barrel drill guide of aspect 1, further
comprising a locking mechanism configured to selectively lock the sliding inserter
in place with respect to the elongated body.
Aspect 3 of the invention relates to the multi-barrel drill guide of aspect 2, wherein
the locking mechanism comprises an opening in the sliding inserter selectively aligned
with an opening in the elongated body extending to the second channel.
Aspect 4 of the invention relates to the multi-barrel drill guide of aspect 1, wherein
the convergence area extends to a single exit point.
Aspect 5 of the invention relates to the multi-barrel drill guide of aspect 4, wherein
the single exit point is at a distal end of the elongated distal guide tube.
Aspect 6 of the invention relates to the multi-barrel drill guide of aspect 1, further
comprising a portion of the second channel which extends at an angle relative to the
longitudinal axis different from the remainder of the second channel.
Aspect 7 of the invention relates to the multi-barrel drill guide system of aspect
1, wherein the second channel curves in a direction away the handle.
Aspect 8 of the invention relates to the multi-barrel drill guide of aspect 1, further
comprising a slit in the exterior of the elongated body extending into the first channel.
Aspect 9 of the invention relates to a multi-barrel drill guide system, comprising:
an elongated body extending along a longitudinal axis having a proximal end and a
distal end with a handle extending from the elongated body between the proximal end
and the distal end;
an elongated distal guide tube attached to and extending distally from the distal
end of the elongated body;
a sliding inserter movably connected to the elongated body such that the slidable
inserter is configured to move between the proximal end and the distal end of the
elongated body;
a first channel extending from the proximal end to the distal end;
a second channel extending from the distal end to a position between the distal end
and the proximal end along the elongated body, the second channel at an angle relative
to the first channel; and
a suture anchor fully positioned within and movable in a slidable manner within the
first channel; and
a drill bit movable in a slidable manner within the second channel.
Aspect 10 of the invention relates to the multi-barrel drill guide system of aspect
9, wherein the suture anchor is loaded onto a driver, which is movable in a slidable
manner within the first channel.
Aspect 11 of the invention relates to the multi-barrel drill guide system of aspect
9, further comprising a locking mechanism configured to selectively lock the sliding
inserter in place with respect to the elongated body.
Aspect 12 of the invention relates to the multi-barrel drill guide system of aspect
11, comprises an opening in the sliding inserter selectively aligned with an opening
in the elongated body extending to the second channel.
Aspect 13 of the invention relates to the multi-barrel drill guide system of aspect
12, wherein in the locked position, the drill bit extends through the opening of the
sliding inserter and the opening in the elongated body into the second channel.
Aspect 14 of the invention relates to the multi-barrel drill guide system of aspect
10, further comprising a shallow deployment button hingedly connected within a recess
on the elongated body.
Aspect 15 of the invention relates to the multi-barrel drill guide system of aspect
14, wherein the driver is connected to the sliding inserter and sliding the driver
distally along the first channel rotates the shallow deployment button away from the
recess.
Aspect 16 of the invention relates to the multi-barrel drill guide system of aspect
9, further comprising a bent portion of the second channel which extends at an angle
relative to the longitudinal axis different from a remainder of the second channel.
Aspect 17 of the invention relates to the multi-barrel drill guide system of aspect
9, wherein the second channel curves in a direction away the handle.
Aspect 18 of the invention relates to a method of drilling a pilot hole and inserting
a suture anchor, the method comprising the steps of:
providing a multi-barrel drill guide and anchor deployment assembly with an elongated
body extending along a longitudinal axis having a proximal end and a distal end with
a handle extending from the elongated body between the proximal end and the distal
end, and an elongated distal guide tube attached to and extending distally from the
distal end of the elongated body, a sliding inserter movably connected to the elongated
body such that the sliding inserter is configured to move between the proximal end
and the distal end of the elongated body, a first channel extending from the proximal
end to the distal end, a second channel extending from the distal end to a position
between the distal end and the proximal end along the elongated body, the second channel
extending at an angle relative to the first channel, and a convergence area at the
distal end where the first channel and the second channel intersect;
inserting a suture anchor loaded on an anchor driver into the first channel;
inserting a drill bit into an opening on the sliding inserter and an opening on elongated
body, which extends into the second channel;
positioning a distal end of the distal guide tube against a bone;
extending the drill bit through the second channel, the convergence area and the distal
guide tube; and
drilling a pilot hole into the bone with the drill bit.
Aspect 19 of the invention relates to the method of aspect 18, further comprising
the steps of:
retracting the drill bit past the opening on the sliding inserter; and
extending the anchor driver through the first channel and the convergence area.
Aspect 20 of the invention relates to the method of aspect 19, further comprising
the step of implanting the suture anchor into the pilot hole.